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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - U-TURBT (A revolutionary shape memory alloy-based disposable device for bladder cancer removal)

Teaser

Summary

Today, approximately 2.5 million people suffer from bladder cancer of different stages globally, with 420,000 newly diagnosed each year. In Europe, a total of 118,000 new cases and 52,000 deaths were estimated annually. Cancerous cells develop in the bladder before eliminating it from the body through urination. Bladder cancer causes bladder infection, blood in urine and change in urination habits such as frequent urination, pain or burning sensation during urination. Commonly, bladder cancer is treated by Trans-Urethral Resection of Bladder Tumour (TURBT) which has up to 61% risk of tumour recurrence resulting into costly repeat operations which can cause scarring to the bladder.
Cancerous cells develop in the bladder due to the old age, smoking, obesity, alcohol drinking and red-meat consumption. Bladder cancer causes bladder infection, blood in urine and change in urination habits such as frequent urination, pain or burning sensation during urination. The current treatment of bladder cancer consists of the use of the ineffective TURBT surgery causing 61% recurrence rate in the patient and causes harmful side-effects such as incontinence and scarring of the bladder in the long term. Moreover, the need for repeated surgeries and other treatments cause excessive economic burden to health-care system and patients.
U-TURBT is an add-on device for the treatment of bladder cancer through an innovative device to perform Trans-Urethral Resection of Bladder Tumour (TURBT). U-TURBT has the shape of an umbrella attached to a resectoscope, the latter being already used in surgeries of the bladder. The umbrella consists of wires made of a patent-protected Shape-Memory Alloy (SMA) platform technology, which changes shape through electrical current. U-TURBT cover and containts the resected tumour cells within to reduce the spillage and disemmination thus reducing the recurrence rate of the bladder cancer in the patient. The overall objectives of the project were to develop and establish define a mvp and establish a sound product development plan. This would be concluded by planning the in field demonstration in a relevant environment to validate the engineering upgrades which were defined during the project.

Work performed

Between 1st February and 31st May 2019, CML undertook a Phase 1 feasibility study under the SME Instrument to determine the technical and economic viability of their U-TURBT system. The assessment confirmed the productâ€™s feasibility. As a result of this feasibility study, the company was able to decide multiple business and technical advancements need for commercialization. CML decided to improve the U-TURBT design by making it slimmer and optimizing the containment process by upgrading the containment material. The company will also improve the U-TURBT control by upgrading the open wire loop as well as power usage by reducing the size of ancillary equipment. CML also plans to upgrade U-TURBT device control firmware and software, and add a porous material as a pressure equalizer for the device to capture tumour cells during the surgery. CML established a partnership with University of Birmingham to perform the pre-clinical validation tests using in vitro method on their premises to test U-TURBT device efficacy, usability and its functionality. The pricing model of the U-TURBT was finalized with the final price of â‚¬500 per unit based on competitors cost of treatment as well as considering patientâ€™s costs and companyâ€™s profitability. CML defined the commercialisation strategy and decided to first release the U-TURBT device in the EU market as a CE-marked medical device. Financial projections were estimated based on the defined business model and CML anticipates achieving annual revenues of â‚¬124.5 million and to reach 48 employees five years after commercialisation.

Final results

The expected outcome of the project is to successfully execute the market validation and demonstrate that the value of SMA technology when applied to the TURBT gold standard surgery. The U-TURBT reduces the healthcare costs by up to 40% thanks to the fact that a second surgery (and relative treatments) is not needed. Additionally U-TURBT eliminates the risk of tumor re-implantation by isolating, cutting and extracting the bladder tumour in a sealed environment, reducing the chance of recurrence by up to 20 in attention to preserving the functionality of the bladder on a day to day basis.